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QT interval prolongation: Sulpiride may induce QT interval prolongation (see Adverse Reactions). It is known that this effect may enhance the risk of serious ventricular arrhythmias such as torsade de pointes.
Before any administration, and if possible considering the patient's clinical condition, it is recommended to monitor the factors that could lead to the onset of rhythm disorders, such as: bradycardia less than 55 bpm, electrolyte imbalance; in particular hypokalaemia; congenital QT interval prolongation; concomitant treatment with medicinal products that can cause bradycardia (< 55 bpm), hypokalaemia, reduction in intracardiac conduction or QT interval prolongation (see Interactions).
Cerebrovascular accident: In randomised, placebo-controlled clinical trials conducted in elderly patients with dementia and treated with certain atypical antipsychotic drugs, it has been observed that the risk of cerebrovascular accidents triples. The increase mechanism for this risk is not known. The increased risk with other antipsychotic drugs or in other types of patient cannot be ruled out. Sulpiride should be used with caution in patients with risk factors for cerebrovascular accidents.
As with other neuroleptics, it may cause neuroleptic malignant syndrome, which is a potentially life-threatening complication characterised by hyperthermia, muscle stiffness and autonomic dysfunction. In case of hyperthermia of a non-diagnosed origin, treatment with sulpiride should be suspended (see Adverse Reactions).
It should be taken into account that Parkinson's patients may experience a worsening of the disease if sulpiride is administered concomitantly with other antidopaminergic agents. It should only be used if the neuroleptic treatment is essential (see Interactions).
The efficacy and safety of sulpiride has not been studied in depth in children. Therefore, its use is not recommended in this group of patients.
Venous thromboembolism: Cases of venous thromboembolism, sometimes fatal, have been observed with antipsychotic drugs. Therefore, sulpiride should be used with caution in patients with risk factors for thromboembolism (see Adverse Reactions).
Use in the Elderly: Elderly patients with dementia: Elderly patients with dementia-related psychosis, treated with antipsychotic drugs, have a higher risk of death. The analysis of seventeen placebo-controlled trials (with a modal duration of 10 weeks), with a large proportion of patients taking atypical antipsychotic drugs, revealed a risk of death in patients treated with medicinal products between 1.6 and 1.7 times the risk of death in patients treated with placebo. In the course of a typical 10-week controlled trial, the death rate in patients treated with a medicinal product was approximately 4.5% compared with approximately 2.6% in the placebo group. Although the causes of death in clinical trials with atypical antipsychotic drugs vary, it appears that the majority of deaths were cardiovascular (e.g. heart failure, sudden death) or infectious (e. g. pneumonia) in nature. Similar to treatment with atypical antipsychotic drugs, as observational studies suggest, treatment with conventional antipsychotic drugs may increase mortality.
It is not clear whether the increased mortality results in observational studies may be attributed to antipsychotic drugs or to some of the patient characteristics.
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